Expedited Review

Expedited does not mean that the review is less rigorous or happens more quickly than convened review. It refers, instead, to certain types of research considered to involve minimal risk.

Expedited review shall be conducted by the IRB chairperson or by one or more of the experienced IRB members designated by the chairperson to conduct the review. The IRB member conducting the expedited review may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. The reviewer shall refer any research protocol which the reviewer would have disapproved to the Full IRB for review. The reviewer may also refer other research protocols to the Full IRB whenever the reviewer believes that Full IRB review is warranted.

When the expedited review procedure is used, the IRB chairperson or member(s) conducting the review shall inform IRB members of research protocols which have been approved under the procedure.

At a convened IRB meeting, any member may request that an activity which has been approved under the expedited procedure be reviewed by the IRB in accordance with non-expedited procedures. A vote of the members shall be taken concerning the request and the majority shall decide the issue.

Eligibility

Expedited review is applicable for research activities that involve no more than minimal risk to the human participants and that can be placed in one or more of the nine categories.

Categories 1 through 7 pertain to both initial and continuing review. Categories 8 and 9 pertain only to continuing review. The definition of minimal risk for the purpose of IRB application is the amount of risk encountered in daily life.

The expedited review procedure cannot be used in the following circumstance:

Where identification of the participants and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

The expedited review procedure may not be used for classified research involving human subjects.

Examples of Commonly Expedited Research

The following types of research are commonly processed under expedited review:

Studies involving collection of hair or saliva samples

Studies of blood samples from healthy volunteers

Studies involving the analyses of voice recordings

Studies involving the collection of identifiable information in surveys, interviews, or focus groups

Studies of existing pathological specimens or data with patient identifiers